A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH

NCT07581951 | Not Yet Recruiting Phase 3

• 1 other identifier: HSK31679-301
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .

Conditions

MASH - Metabolic Dysfunction-Associated Steatohepatitis; NASH (Non-Alcoholic Steatohepatitis)

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.

  Resolution of steatohepatitis is defined as total absence of ballooning (score=0) and absent or mild inflammation (score 0 to 1). Worsening of fibrosis is defined as progression of fibrosis by ≥1 stage.

  Week 52

• Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.

  Worsening of steatohepatitis is defined as increase in non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) for ballooning, inflammation, or steatosis.

  Week 52

• Time to First Occurrence of Disease Progression

  Final analysis of the time to first occurrence of disease progression will be measured by a composite of protocol-specified clinical events

  Up to 4.5 years

Study Arms (2)

HSK31679 dose

EXPERIMENTAL

HSK31679 tablet, orally, once daily

Drug: HSK31679

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK31679 DRUG

tablet

HSK31679 dose

Placebo DRUG

Matching tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Must be willing to participate in the study and provide written informed consent.
• Male and female adults ≥ 18 years of age.
• Have at least one cardiometabolic risk factors at screening.
• MRI-PDFF fat fraction ≥8%.
• Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \< F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.
• Body weight fluctuation \< 5% for at least 6 weeks before randomization.

You may not qualify if:

• \. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.
• MELD score ≥12 due to hepatic disease。
• Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).
• Participants who had not been on stable medication with vitamin E (dose\>400 IU/day) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).
• Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.
• HbA1c ≥ 8.0%.
• Chronic liver diseases other than NASH.
• Active autoimmune disease. 9.Serum ALT \> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \< 2 years.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

fangqiong li

CONTACT

028-67258840; lifangq@haisco.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 30, 2032
• Last Updated: June 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share